HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery — HISTAP  

Blood Pressure Clinical Trial

Official title: HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial.

Status Recruiting

Clinical Trial Summary

This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.

Clinical Trial Description

Intraoperative hypotension has been associated with major postoperative complications after non-cardiac surgery. However, is is still unclear the optimal intraoperative mean arterial pressure (MAP) target in the subgroup of those patient with an history of hypertension at home, and at risk of developing postoperative complications.

The objective of this study is to assess the effects of an intraoperative blood pressure management strategy aiming at keeping the MAP ≥ 80mmHg), as compared to the conventional practice (to maintain intraoperative MAP ≥ 65mmHg), on a composite outcome considering the death rate and the incidence of major events in patient scheduled for elective laparotomic/laparoscopic surgery.

The primary outcome is a composite of 30-days from operation mortality rate and at least one major organ dysfunction including the renal, respiratory, cardiovascular and neurologic systems or new onset of sepsis and septic shock occurring by day 7 after surgery. ;

Related Conditions & MeSH terms

• Blood Pressure
• Complication,Postoperative
• Hypotension
• Intraoperative Hypotension
• Postoperative Complications

• NCT number: NCT05637606
• Study type: Interventional
• Source: Humanitas Clinical and Research Center
• Contact: Antonio Messina
• Phone: +390282241
• Email: antonio.messina@humanitas.it
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Completion date: January 31, 2025